LEADS WITH SEGMENTED ELECTRODES AND METHODS OF MAKING AND USING THE LEADS

• US 20150018915A1
• Filed: 07/07/2014
• Published: 01/15/2015
• Est. Priority Date: 07/12/2013
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Leven, Jacob B.
• Granted Patent: US 9,289,596 B2
• Time in Patent Office: Days
• US Class Current: 607/116
• CPC Class Codes: A61B 2562/125 characterised by the manufacture of electrodes
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: Y10T 29/49176 with molding of electrically insulating material

Abstract

A method of making a stimulation lead includes disposing a pre-electrode along a distal end portion of a lead body. The pre-electrode includes a body having a central hub and stimulation members individually coupled to the central hub and extending radially-outward therefrom such that each of the stimulation members is electrically-coupled to each of the remaining stimulation members solely via the central hub. Conductors extending from terminals disposed along a proximal end portion of the lead body are electrically-coupled to each of the stimulation members. Electrically-nonconductive material is disposed around longitudinal surfaces of the central hub with the electrically-nonconductive material abutting inner surfaces of the stimulation members. The central hub is removed from the pre-electrode body to electrically isolate each of the stimulation members from one another, thereby transforming the stimulation members into electrically-isolated segmented electrodes disposed along the electrically-nonconductive material.

Claims

1. A method of making a stimulation lead, the method comprising

disposing at least one pre-electrode along a distal end portion of a lead body, the at least one pre-electrode comprising a pre-electrode body having a proximal end and a distal end, the pre-electrode body comprising

an electrically-conductive central hub,

a plurality of electrically-conductive stimulation members individually coupled to the central hub and extending radially-outward therefrom such that each of the plurality of stimulation members is electrically-coupled to each of the remaining plurality of stimulation members solely via the central hub;

electrically-coupling at least one conductor of a plurality of conductors extending from a plurality of terminals disposed along a proximal end portion of the lead body to each of the plurality of stimulation members;

disposing electrically-nonconductive material around longitudinal surfaces of the central hub with the electrically-nonconductive material abutting inner surfaces of the plurality of stimulation members; and

removing the central hub from the pre-electrode body to electrically isolate each of the plurality of stimulation members from one another, thereby transforming the plurality of stimulation members into a plurality of electrically-isolated segmented electrodes disposed along the electrically-nonconductive material.

2. The method of claim 1, wherein disposing at least one pre-electrode along a distal end portion of a lead body comprises disposing along the distal end portion of the lead body at least one pre-electrode that comprises a plurality of connector elements electrically coupling the plurality of stimulation members to the central hub.

3. The method of claim 1, wherein disposing at least one pre-electrode along a distal end portion of a lead body comprises disposing along the distal end portion of the lead body at least one pre-electrode that comprises exactly three electrically-conductive stimulation members.

4. The method of claim 1, wherein removing the central hub to electrically isolate each of the plurality of stimulation members from one another comprises passing a drill along a portion of the lead body that includes the central hub to remove the central hub and sever connections between the plurality of connector elements, the passing of the drill forming a central lumen along at least a portion of the lead body.

5. The method of claim 1, further comprising disposing insulating material along walls of the central lumen to electrically isolate the segmented electrodes from the central lumen.

6. The method of claim 5, wherein disposing insulating material along walls of the central lumen comprises re-flowing electrically-nonconductive tubing along the walls of the central lumen.

7. The method of claim 5, wherein disposing insulating material along walls of the central lumen comprises depositing electrically-nonconductive material using chemical vapor deposition along the walls of the central lumen.

8. The method of claim 5, wherein disposing insulating material along walls of the central lumen comprises injection molding electrically-nonconductive material along the walls of the central lumen.

9. The method of claim 1, wherein disposing electrically-nonconductive material around longitudinal surfaces of the central hub with the electrically-nonconductive material abutting inner surfaces of the plurality of stimulation members comprises disposing electrically-nonconductive material around longitudinal surfaces of the central hub with the electrically-nonconductive material flush with outer surfaces of the plurality of stimulation members.

10. A pre-electrode for a stimulation lead, the pre-electrode comprising:

a substantially-cylindrical pre-electrode body having a proximal end and a distal end, the pre-electrode body comprising

an electrically-conductive central hub having a longitudinal surface,

a plurality of connector elements extending radially outward from the longitudinal surface of the central hub, the plurality of connector elements each having a medial end coupled to the central hub and an opposing lateral end, and

a plurality of stimulation members each having an inner surface and an outer surface, the inner surface of each of the plurality of stimulation members coupled to the medial end of at least one of the plurality of connector elements such that each of the plurality of stimulation members is electrically-coupled to each of remaining stimulation members of the plurality of stimulation members solely via the central hub.

11. The pre-electrode of claim 10, wherein the central hub is tube-shaped.

12. The pre-electrode of claim 10, wherein the inner surface of each of the plurality of stimulation members is coupled to the medial end of exactly one connector element of the plurality of connector elements.

13. A stimulation lead comprising:

a lead body comprising a longitudinal surface, a distal end portion, a proximal end portion, and a longitudinal length, the lead body formed from a lead-body material;

a central lumen extending along the longitudinal length of lead body, the central lumen bounded by longitudinal walls;

insulating material disposed at the distal end portion of the lead body between the lead body and the central lumen, wherein the insulating material is a different material from the lead-body material;

a plurality of terminals disposed along the proximal end portion of the lead body;

a plurality of electrodes disposed along the distal end portion of the lead body, the plurality of electrodes comprising a plurality of segmented electrodes, each of the plurality of segmented electrodes comprising

a stimulation member having an outer surface and an opposing inner surface, and

a connector element coupled to the inner surface of the stimulation member and extending radially inward to the insulating material; and

a plurality of conductors electrically coupling the plurality of terminals to the plurality of electrodes.

14. The stimulation lead of claim 13, wherein the stimulation member of at least one of the plurality of segmented electrodes further comprises at least one lead-retention feature.

15. The stimulation lead of claim 14, wherein the at least one lead-retention feature comprises at least one barb disposed along the inner surface of the stimulation member of the segmented electrode.

16. The stimulation lead of claim 14, wherein the at least one lead-retention feature comprises at least one barb disposed along the connector element of the segmented electrode.

17. The stimulation lead of claim 14, wherein the at least one lead-retention feature comprises at least one undercut formed along the stimulation member of the segmented electrode.

18. The stimulation lead of claim 13, wherein the plurality of electrodes comprises at least one ring electrode.

19. The stimulation lead of claim 13, wherein the plurality of electrodes comprises at least one tip electrode.

20. The pre-electrode of claim 13, wherein plurality of stimulation members comprises three stimulation members.